Portable device with disposable reservoir for collection of internal fluid after surgery

ABSTRACT

A system and apparatus for the collection of serous or serosanguinous fluid from a percutaneous site after surgery. A pump unit with one or more pumps or powered sources provide continuous negative pressure suction to draw fluid from the percutaneous site and pumps the fluid into disposable reservoirs with one-way valves that are easy to handle while maintaining sterility and a seal to prevent the loss of vacuum. Air is continuously removed from the reservoirs. Measurement and analysis of the output is performed automatically.

This application claims benefit of and priority to U.S. ProvisionalApplications Nos. 62/340,853, filed May 24, 2016, and 62/409,400, filedOct. 18, 2016, and is entitled to priority to those filing dates. Thespecifications, drawings, appendices, and complete disclosures of U.S.Provisional Applications Nos. 62/340,853 and 62/409,400 are incorporatedherein by specific reference for all purposes.

FIELD OF INVENTION

This invention relates to medical devices, particularly those used todrain serous or serosanguinous fluid from the percutaneous site aftersurgery.

BACKGROUND OF THE INVENTION

In order to drain the fluid which naturally builds up after surgeriessuch as mastectomies, abdominoplasties, panniculectomies, hernia repair,and the like, surgeons place drains attached to reservoirs which collectthe bodily fluids for a period of time ranging from several days toseveral months. Once the bulbs are filled, the patient or an aideempties the contents into a measuring cup, measures and reports theamounts of collected fluid to the healthcare provider. The dailycollected amount is the determinant of the clinical decision, i.e., theremoval of the drains. Patients strongly dislike the drains due toquality of life issues, but yet it is their self-reported values thatdetermine the clinical course. This conflict of interest jeopardizes theoptimal care of the patient.

Despite prior attempts to reduce the risk of postoperative seromas dueto large flap forming surgeries, no single technique has been shown toeliminate the risk completely. Current solutions are passive, tend toclog, are ineffective in removing fluid, are much disliked by patientsand healthcare providers, and lack any diagnostic capability.

One of the major issues with post-surgical fluid management is thestorage of the collected fluids. There are large amounts of fluid thatis collected in patients who undergo large void-forming surgeries. Thisresults in large volumes to be collected, measured, and emptied. Thepatients wear graduated bulbs in which fluid is collected and measuredby patients themselves. Multiple issues relate to this: (1) fluid iscollected only after all the air is removed from the abdomen; (2)patients have to pour the fluid in a measuring cup, measure, record, andreport to their healthcare provider, (3) maintenance of sterility isdifficult. In order to effectively remove the fluid in a continuousmanner, air must be removed from the collection reservoir. Otherwise,either the reservoir is filled quickly with air/liquid mixture andemptying must take place to remove fluid often, or the reservoiroverfills leading to high pressure levels and possibly backflow.

Devices which are designed to remove serous or serosanguinous fluid fromthe internal percutaneous space of a patient after surgery arecumbersome for patients to manage, and apply severely limited pressureto the internal space resulting in ineffective drainage and thedevelopment of blockages in the drainage lines.

Accordingly, there is a need for a device that that addresses theseproblems and issues with a comprehensive approach.

SUMMARY OF INVENTION

In various exemplary embodiments, the present invention comprises asystem and apparatus for the collection of serous or serosanguinousfluid from the percutaneous site after surgery. There are large amountsof fluid that collect in patients who undergo large void-formingsurgeries. This results in large volumes to be collected, measured, andemptied. In order to effectively remove the fluid in a continuousmanner, air must be removed from the collection reservoir. Otherwise,either the reservoir is filled quickly with air/liquid mixture andemptying must take place to remove fluid often, or the reservoiroverfills leading to high pressure levels and possibly backflow.

In several embodiments, the present invention makes use of a poweredsource of negative pressure which helps overcome clogging observed inprior art devices, and one or more reservoirs which allow excess air tobe removed. The invention comprises disposable reservoirs with one-wayvalves that are easy to handle while maintaining sterility and a seal toprevent the loss of vacuum. The present invention further providescontinuous negative pressure suction which assists in providing constantdrainage. Prior art devices do not provide a means of applyingcontinuous negative pressure to the percutaneous wound site.

In addition, the measurements of the output can be performedautomatically, relieving the need for the patient to performmeasurements directly (and thus resolving the potential conflict ofinterest in self-measuring so that the best clinical decisions can bemade). The measurements of output can be relayed to the caregiver,doctor, or the nurse via wired or wireless communications, and enablespatients who do not have companions to manage their drain care. There isa potential diagnostic value in taking various measurements associatedwith the collected fluid. Measurements can include and are not limitedto collected fluid amount, pH, certain known harmful mediators(cytokines, chemokines, reactive oxygen species), protein levels, bloodcontent, etc. For example, amount of fluid collected can be an indicatorof possible seroma development in some hernia surgeries. Additionally,pH has also been shown to act as an indicator of possible seromaformation. The present invention thus allows for the detection ofinfectious materials, and any other chemicals or substances which mayindicate infection, or the presence of some medical condition which maynaturally arise in response to the surgical procedure, initialpathology, or additional complications (of either the surgical procedureor the initial pathology) in the fluid collected from percutaneous(internal) wounds.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an exemplary embodiment of the deviceand patient.

FIG. 2 is a perspective view of one embodiment of the deviceincorporated into an abdominal binder.

FIG. 3 is a perspective view of one embodiment of the deviceincorporated into a bra for use after mastectomy.

FIGS. 4A-B are views of exemplary embodiments of drainage structureswhich may be connected to the source of negative pressure.

FIG. 5 is a perspective view of one embodiment of the pump device.

FIG. 6 is a perspective view of one embodiment of the fluid reservoir.

FIG. 7 is a schematic of one embodiment of the device communicationfeatures.

FIG. 8 is a schematic of a different embodiment of the devicecommunication features.

FIG. 9 is a perspective view of one embodiment of a device used tofasten the device to the patient (e.g., abdominal binder, mastectomybra, and the like).

FIG. 10 is a cutaway view of one embodiment of the multiple tubing inputmanifold.

FIG. 11 is a view of one embodiment of a mechanism to prevent excesspressure for building up against the outlet one-way valve.

FIG. 12 is a view of one embodiment of a mechanism to allow thepreservation of the “stripping” or “milking procedure”, and also allowsfor the collection of large materials which may be problematic for thepumps in the device.

FIG. 13 is an exploded view of one embodiment of the device described inthis document.

FIG. 14 is an assembled view of one embodiment of a pump unit inaccordance with an exemplary embodiment of the present invention.

FIG. 15A is a perspective view of the pump housing of FIG. 14.

FIG. 15B shows front and end views of the pump housing of FIG. 15A.

FIG. 15C shows a bottom view of the pump housing of FIG. 15A.

FIG. 16 shows a top view of an alternative embodiment of a pump unit andreservoir.

FIG. 17 shows a perspective view of the pump unit and reservoir of FIG.16.

FIG. 18 shows a top view of the pump unit and reservoir of FIG. 16.

FIG. 19 shows another perspective view of the pump unit and reservoir ofFIG. 16.

FIG. 20 shows a perspective view of the pump unit with cover removed andreservoir of FIG. 16.

FIG. 21 shows a top view of the pump unit with cover removed andreservoir of FIG. 16.

FIG. 22 shows a top view of the pump unit with batteries exposed andreservoir of FIG. 16.

FIG. 23 shows a perspective view of the pump unit and reservoir of FIG.22.

FIG. 24 shows a view of inlet ports with mesh.

FIGS. 25A-C show views of inlet ports with a rotary blade.

FIGS. 26A-D show views of a reservoir connection unit with integratedfilters.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

In various exemplary embodiments, the present invention comprises asystem and apparatus for the collection of serous or serosanguinousfluid from the percutaneous site after surgery. There are large amountsof fluid that collect in patients who undergo large void-formingsurgeries. This results in large volumes to be collected, measured, andemptied. In order to effectively remove the fluid in a continuousmanner, air must be removed from the collection reservoir. Otherwise,either the reservoir is filled quickly with air/liquid mixture andemptying must take place to remove fluid often, or the reservoiroverfills leading to high pressure levels and possibly backflow.

In several embodiments, the present invention makes use of a poweredsource of negative pressure which helps overcome clogging observed inprior art devices, and one or more reservoirs which allow excess air tobe removed. The invention comprises disposable reservoirs with one-wayvalves that are easy to handle while maintaining sterility and a seal toprevent the loss of vacuum. The present invention further providescontinuous negative pressure suction which assists in providing constantdrainage. Prior art devices do not provide a means of applyingcontinuous negative pressure to the percutaneous wound site.

In addition, the measurements of the output can be performedautomatically, relieving the need for the patient to performmeasurements directly (and thus resolving the potential conflict ofinterest in self-measuring so that the best clinical decisions can bemade). The measurements of output can be relayed to the caregiver,doctor, or the nurse via wired or wireless communications, and enablespatients who do not have companions to manage their drain care. There isa potential diagnostic value in taking various measurements associatedwith the collected fluid. Measurements can include and are not limitedto collected fluid amount, pH, certain known harmful mediators(cytokines, chemokines, reactive oxygen species), protein levels, bloodcontent, etc. For example, amount of fluid collected can be an indicatorof possible seroma development in some hernia surgeries. Additionally,pH has also been shown to act as an indicator of possible seromaformation. The present invention thus allows for the detection ofinfectious materials, and any other chemicals or substances which mayindicate infection, or the presence of some medical condition which maynaturally arise in response to the surgical procedure, initialpathology, or additional complications (of either the surgical procedureor the initial pathology) in the fluid collected from percutaneous(internal) wounds.

FIG. 1 shows an exemplary embodiment of the present system. Drainagestructures 3 begin in the percutaneous space, extend through thepercutaneous tissue at an exit site 2 and terminate in themultiple-drainage-structure manifold 4. A pump 6 creates a negativepressure in the connection 5 between the pump 6 and manifold 4 andimparts a negative pressure to the single or multiple drainagestructures 3. The pump 6, by employing either a peristaltic mechanism,positive displacement, or some other source conveys positive pressure tothe collected fluid after it enters the pump unit, which causes thefluid to be transported to the disposable reservoir 8. A series of oneway valves which may be placed at either one or all of the followinglocations ensure the prevention of backflow: at the manifold entrance,pump entrance and exit, and reservoir entrance.

The pump 6 is controlled by means of an onboard processor which may takeas inputs from the user the following: on/off; desired pump pressure;and device communication parameters (i.e., mobile device connectivityand the selection of default mobile device). Additionally, the onboardprocessor may take as inputs from the device the following: pumppressure differential (between exit 2 and pump entrance); flow rate atmanifold (for each individual drainage structure or for all drainagestructures combined); motor current draw; device orientation withrespect to force of gravity (from accelerometer); presence of bacterialor pathogenic substances; immune system indicators; battery chargelevel; or any value relevant to the operation of the device.

The device may communicate via Bluetooth or some other communicationprotocol (e.g., BLE, NFC) to a mobile device or to a larger cellularnetwork in order to provide information regarding the performance of thedevice (e.g., battery charge level, need to change reservoir, devicetemperature, current magnitude of negative pressure, presence ofblockage in tubing, or any other relevant information which may be ofbenefit to either the patient, their nurse, their doctor, theircaregivers, their family, or any interested party) and thecharacteristics of the collected fluids. These characteristics mayinclude, but are not limited to, the following: total collected amount(either total or per drainage structure); rate of fluid collection(total or per drainage structure) over one or more time scales (e.g.,hours, days, or weeks); presence of infectious materials; and thepresence of any other chemicals or substances which may indicateinfection or the presence of some medical condition which may naturallyarise in response to the surgical procedure, initial pathology, oradditional complications (of either the surgical procedure or theinitial pathology) in the fluid collected from percutaneous (internal)wounds. This information may be relayed to a mobile computing device,personal computer, or any computer or database system which may beaccessed by the staff of an inpatient or outpatient medical center, thepatient, their nurse, their doctor, their caregivers, their family, orany interested party as allowed by law. This information may be accessedby a purposefully designed mobile application on the mobile computingdevices of the patient, their nurse, their doctor, their caregivers,their family, or any interested party as allowed by law.

FIG. 2 shows a perspective view of a pump 9, manifold 10, and disposablereservoir 11 placed onto an abdominal binder 8. This arrangementcomprises a single unit generally placed at the end of the surgicalprocedure. The device components may connect to the binder by means of aremovable fastening system so that it may be removed from the binder tofacilitate patient comfort. Additionally, the binder may incorporatesome means to secure the drainage structure (drainage tubing) at thesurgical exit site, and along its path to the pump unit. Furthermore thebinder may fasten to itself (forming a continuous loop) by means ofhook-and-loop fabric connection, buckle connector, or button snapconnector(s). The location at which the pump unit attaches to theabdominal binder may incorporate some means of heat mitigation, such as,but not limited to, an open-cell foam pad, or gel-filled plastic pouchtype pad.

In an alternative embodiment, FIG. 3 shows a perspective view of acombined pump, manifold, and disposable reservoir unit 14 placed on abra 13 or mastectomy binder, which is commonly used following amastectomy procedure. This allows a single unit which is generally to beplaced at the end of the surgical procedure. The device 14 may connector be attached to the bra 13 by means of a removable fastener (asdescribed above) so that it may be removed from the binder to facilitatepatient comfort. Additionally, the bra may incorporate some means tosecure the drainage structure (drainage tubing) at the surgical exitsite, and along its path to the pump unit.

FIGS. 4A-B shows views of possible internal drainage structures placedinside of the percutaneous space at the time of surgery. A hollowflexible tube 16, 18 may be perforated, or may incorporate some crosssection which facilitates the drainage of fluid and prevents tissueingrowth into the tubing. Scaffolding 15, 19 holds the drainagestructure in the conformation which increases surface area. Thescaffolding units may be biodegradable or resorbable, and mayincorporate different geometry, number, or conformation than shown inthe figures. Additionally, these scaffolding units may incorporateantibacterial substances, or any substance which may aid in the tissueapposition of the wound space, healing, infection prevention, blood clotformation, or any other medically useful property. The scaffolding mayadhere to the surface of the drainage tubing, or may incorporate suchgeometry as is necessary to allow the scaffolding to completelyencapsulate the drainage tubing at the points of intersection. Thedrainage structure continues 17 through the percutaneous tissue throughthe exit site and terminates at the fluid collection unit or drainagebulb. While the drainage structures shown in FIGS. 4A-B are embodimentsof the unique drainage structure, many other possible configurations arepossible which utilize resorbable or biodegradable scaffolds to form thegeometry of the drainage suture.

FIG. 5 shows a perspective view of one embodiment of the pump mechanism.The top housing (front 28 and rear 23) provides the main structuralsupport for the device, and may also provide the contact path necessaryfor the peristaltic action or positive displacement to occur.Furthermore, it may house all necessary electronic components whichinclude, but are not limited to, the microprocessor/microcontroller, thebattery charging components, the user interface components (buttons,switches, displays), the communication components and circuitry, and allnecessary wiring and small components. The peristaltic action isaccomplished by the central rolling mechanism 21 sequentiallycompressing the internal tubing 22 which may consist of silicone rubberor any similar flexible material which may have desirable properties forthis application. The driving force needed to rotate the central rollingmechanism is provided by an electric motor 20 which may be powered byeither a rechargeable or a non-rechargeable battery source. In oneembodiment, the motor is a 6V DC motor with a 90 degree output shaft inorder to reduce the overall device profile. The majority of theelectrical components are contained within the rear device housing 23.This also provides some storage space for batteries.

Sterile, one-way valves 27 prevent backflow of the fluid at both thepump entrance, and also at the pump exit (reservoir entrance). Fluid istransferred from the pump to the reservoir 25 through either directconnection or via additional tubing 24 to allow the reservoir to beplaced at a distance away from the pump. The reservoir may be eithersoft flexible plastic or a hard, rigid container, or a combination ofboth in which a flexible plastic pouch is placed within a rigid outercontainer. As the reservoir 24 is placed downstream from the pump unit,it must provide for the release of excess air which may otherwise becometrapped in the reservoir. Air-permeable, liquid-impermeable membranesmay be incorporated into the reservoir in order to allow this air toescape. Furthermore the entire reservoir may be comprised of anair-permeable, liquid-impermeable material.

The pump unit may have features which allows it to be easily attached toan abdominal binder, mastectomy binder, or other means of securing thedevice to the patient. Additionally, an insulator (not illustrated) maybe attached to the external surface of the rear device housing 23 toprotect the patient/user from any excess heat generated by the deviceitself during operation. In a further exemplary embodiment, a soundinsulator/reduction component or structure to reduce the sound wavesgenerated by the unit may also be attached to the external surface ofthe rear device housing. The sound insulator/reduction component mayreduce both actual sound volume as well as amplitude thereof, in orderto provide a more comfortable situation for the patient/user.

FIG. 6 shows a cutaway view of an embodiment of the reservoir. Thereservoir is compartmentalized by segmenting structures 34 (in the caseof a rigid reservoir) or by the heat-sealed or pressed structure (in thecase of a flexible pouch-like reservoir). These segmenting structuresprevent the splashing or excessive or irregular movement of fluid 200 inthe reservoir, and provide a sequential filling order of the reservoirto limit the amount of fluid present in the final segment, in whichgas-permeable, liquid-impermeable membranes 32 allow the escape of air.Fluid 200 is transferred from the pump unit into the reservoir through aquick-release connection 28. A one-way valve 29 prevents the backflow offluid when disconnecting the reservoir from the pump unit. A significantdistinction between this reservoir and prior art devices is that thereservoir of the present invention is designed to be disposed of andreplaced by a new, clean reservoir each time the fluid fills areservoir. This significantly improves the patient experience in thatthey no longer must empty the drain reservoir and replace it.

At the end of the reservoir furthest from the intake connection 28 is achamber which may contain some compound 33, such as activated carbon,which both hinders the flow of fluid should it gain entry to thechamber, but also removes any odor from the air which is to be releasedfrom the reservoir. A mesh (foam or otherwise) filter 31 prevents excessfluid from backing up against the first gas-permeable,liquid-impermeable membrane 32. The end segment is constructed in such away as to maximize gas release, and minimize the leakage of fluid. Inthe embodiment shown, three sequential membranes 32 are utilized inorder to prevent the escape of fluid from the reservoir.

Additionally, the reservoir may make use of an onboard system(electronic or otherwise) for measuring certain characteristics of thecollected fluid. These characteristics may include, but are not limitedto, the following: total collected amount; rate of fluid collection onthe time scales of hours, days, or weeks; presence of infectiousmaterials; and any other chemicals or substances which may indicateinfection; or the presence of some medical condition which may naturallyarise in response to the surgical procedure, initial pathology, oradditional complications (of either the surgical procedure or theinitial pathology) in the fluid collected from percutaneous (internal)wounds.

For example, in one embodiment the reservoir may make use of afluorescent-based assay for detecting the presence of bacteria, by usinga photosensitive sensor to detect the light emitted by excitation of thefluorescent compound in the presence of bacteria. The reservoir may alsomake use of external graduation markings in combination with atransparent material to allow easy monitoring of fluid collection.Furthermore, in the case of a flexible reservoir design, the reservoirmay comprise an internal pouch and an external rigid structure. As thepouch expands and reaches its maximum fill level, it may actuate a limitswitch or proximity switch indicating the reservoir is nearing totalcapacity.

FIG. 7 shows a schematic of one embodiment of a communication channelbetween the pump device 35 and the devices 35, 36 of the staff of aninpatient or outpatient medical center, the patient, their nurse, theirdoctor, their caregivers, their family, or any interested party asallowed by law. This communication is designed to relay informationregarding the function of the device, or the characteristics of thecollected fluid, as described previously. The pump device 35communicates wirelessly with the patient's mobile device 36, tabletcomputer, or personal computer by either device-to-device communicationor by utilizing a local wireless local area network or a cell network.The information received by the patient's device is then relayed in alike fashion (device-to-device, wireless local area network, cellnetwork) to the mobile devices 37, tablet computers, or personalcomputers of the staff of an inpatient or outpatient medical center, thepatient's nurse, their doctor, their caregivers, their family, or anyinterested party as allowed by law. Any of these devices, or the pumpdevice itself, may make treatment recommendations or diagnoses based onthe information gained from the collected fluid.

FIG. 8 shows another embodiment of a communication channel between thepump device 38 and the devices 39, 40, 41, 42 of the staff of aninpatient or outpatient medical center, the patient, their nurse, theirdoctor, their caregivers, their family, or any interested party asallowed by law. This communication is designed to relay informationregarding the function of the device, or the characteristics of thecollected fluid as described previously. The pump device 38 communicateswirelessly with the mobile devices, tablet computers, or personalcomputers of the staff of an inpatient or outpatient medical center, thepatient 39, the patient's nurse, their doctor, their caregivers, theirfamily, or any interested party as allowed by law 40, 41, 42. Any ofthese devices, or the pump device itself may make treatmentrecommendations or diagnoses based on the information gained from thecollected fluid.

FIG. 9 is a perspective view of an exemplary embodiment of an apparatus43 which may function as an abdominal binder, mastectomy bra, or anyother means of attaching the pump device and reservoir to the patient.The apparatus 43 is constructed from fabric or other suitable material,and is backed with a padding or other material 43 a which increases thecomfort to the patient, such as, but not limited to, foam or gelpadding. A series of ports 46 which allow the drainage tubing to passthrough the apparatus are provided at various locations around theapparatus, and may be present in a repeating pattern or spacing. Theapparatus may incorporate a greater or lesser number of these ports thanshown in FIG. 9.

A tubing channel 44 is provided in the apparatus to allow convenientrouting of the drainage tubing. This channel may secure the tubing bymeans of folding a section hook-and-loop fastener fabric over the tubingalong the length of device or portions thereof. The channel also maycomprise several snap-fit clamps along the length of the apparatus.

A magnified view 48 of the pass-through ports 46 shows in detail theconstruction of the port. The port comprises a foam portion which hasbeen pre-punched or pre-cut 47 in such a way as to allow easy removal ofthe section of foam which has a diameter close to the diameter of thedesired drainage tubing. By incorporating this feature, surgeons maymake use of any diameter drainage tubing, or may utilize severaldifferent sizes of tubing at different locations.

A fastening feature 45 allows the apparatus to be removed easily. Thefeature may function by means of hook-and-loop fabric, button snaps,buckle fasteners, or clasps. The apparatus may also include some featurefor mounting the pump and reservoir, or any other desired peripheraldevices. This feature will match a corresponding feature on the pump andreservoir to allow quick and easy removal, in a manner similar to thatdescribed above. The device also may feature some other means ofsecuring the drainage tubing.

FIG. 10 is a cutaway view of one embodiment of the manifold at the pumpentrance. This manifold allows the connection of one or many drainageinputs. In this embodiment, four input connections are shown; howeverthe manifold may comprise fewer inputs or greater inputs. Each drainagetubing line 49 is secured to the manifold by a connector 50 (which maybe a barbed fitting and quick-disconnect combination). This connector 50may allow for the input of many different sizes of drainage tubing viaadaptor fittings or through inherent design. Downstream of the connectoris a one-way valve 51 which prevents backflow of the fluid.

Within the body 54 of the manifold are channels 52 which accept thefluid after the one-way valve 51. These channels 52 direct the fluidinto separate measurement units 53 which collect information about thecharacteristics of the collected fluid. These characteristics mayinclude, but are not limited to, the following: total collected amount;rate of fluid collection on the time scales of hours, days, or weeks;presence of infectious materials; and any other chemicals or substanceswhich may indicate infection, or the presence of some medical conditionwhich may naturally arise in response to the surgical procedure, initialpathology, or additional complications (of either the surgical procedureor the initial pathology) in the fluid collected from percutaneous(internal) wounds. This information may then be relayed to an onboardprocessor 58 for additional processing before being forwarded on to theprocessor in the pump device. A collection unit 55 channels all fluidinto single channel. The manifold may include another one-way valve 56at the exit 57 which may make use of a quick-disconnect connector or maytransfer the fluid directly the pump unit. In this embodiment, themanifold, itself, does not possess any means of moving the collectedfluid but rather relies on the action of the downstream pump device. Themanifold may be separable from the pump device or may be a continuousmolded unit with the body of the pump device.

FIG. 11 shows an overview of a unique mechanism within the peristalticpump device which prevents a high pressure in the system downstream fromthe central rolling unit 63. This is useful particularly when thereservoir is removed from its connection to the upstream collectedfluid. A one-way valve or valves may be positioned both before and afterthe reservoir connection, and the upstream valve likely will have someresidual pressure against it which may cause an amount of fluid to leakwhen the reservoir is disconnected. This mechanism allows the centralrolling unit to automatically reverse, i.e., turn in a directionopposite the direction it must turn to normally pump the fluid. This isachieved via a spring 65 at the attachment between the motor outputshaft 64 and the body of the central rolling unit 63. When the motor isstopped the spring naturally unwinds or uncoils, causing the centralrolling unit to turn with it some amount. This causes the point at whichthe rollers contact the tubing 66 to shift, causing the fluid to bepushed backwards opposite its normal flow direction. A section ofcompliant tubing 60 allows the influx of excess fluid without causing ahigher than optimal pressure to develop in the tubing. A one-way valve59 prevents the fluid from back flowing through the pump entrance 58.The arrows 58 and 67 show the normal direction of fluid transport. Thedirection of fluid transport caused by this mechanism (when the motor isstopped) is opposite the direction denoted by the arrows. Not shown isthe pump housing, which holds all components and allows the peristalticaction of the pump.

FIG. 12 is an overview of one embodiment of a mechanism to allow thepreservation of a “stripping” or “milking procedure”, and also allow forthe collection of large materials, which can cause problems in thepump(s). The “milking” or “stripping” procedure is currently prescribedas a method to clear blockage in the drainage structure, and calls forthe user to apply pressure using their fingers to the tubing above theblockage and, in a peristaltic nature, moving their fingers down thetubing past the blockage, promoting a restored flow. As severalexemplary embodiments of the present utilize a peristaltic pump, whichoccludes flow if stopped, some mechanism is needed to accommodate the“stripping” or “milking” procedure. This mechanism consists of one ormore one-way valves 68 (generally one per drainage connection)immediately after the connection to the drainage structure, whichprevents backflow of fluid or particles into the tubing. Immediatelydownstream of the one-way valve is a chamber (or chambers) 70 to receivefluid and particles, the latter of which may potentially blockdownstream components in the device and inhibit flow. At the exit ofthis chamber is a filter or screen 69, which prevents larger particlesfrom moving further downstream. This entire chamber may be removable, inwhich case seals 74 are incorporated to prevent fluid leakage byoccluding the gap necessary to facilitate removal of the chamber.Downstream of this chamber, the tubing bifurcates with one channelfacilitating fluid transport to the pump(s) 71 and a second “bypass”channel facilitating fluid transport around the pump when the “milking”or “stripping” procedure is performed. A one-way valve 73 is placed inthe second channel to prevent backflow of fluid during normal pumpoperations. The valve remains closed, and the bypass channel thus isshut-off to fluid flow during normal operations. The two tubing channelsconverge to a single channel downstream from the pump and one-way valve,facilitating fluid transport to the remainder of the device 72 or to theoutput reservoir.

FIG. 13 is an exploded view of an exemplary embodiment of an assembleddevice incorporating the elements described above. Fluid inletconnectors 86 (either barbed or otherwise) allow for the connection ofone or multiple drainage structures or tubes (as described above) to thepump unit of the device. In this embodiment, two drainage structures areaccommodated; however, additional structures may be provided for byincluding additional assemblies of the relevant components. For eachfluid inlet, immediately downstream of the connector is a one-way valve,as described above, to prevent the backflow of material into thedrainage structure. Downstream of the one-way valve is a fluid chamber82, which includes a pressure sensor 84 to monitor the pressuredeveloped in the device. Tubing allows fluid from this chamber to flowinto a peristaltic, or positive displacement, pump 83, which appliesnegative pressure on the upstream side of the pump, and positivepressure on the downstream side. This positive pressure downstream ofthe pump causes fluid to be transported through the remainder of thepump housing body and connection elements to a reservoir unit 77.

A set of one-way valves 79, 80 may be incorporated at the connectionbetween the pump housing body and the reservoir to prevent fluid leakageduring change of reservoirs. The reservoirs may be collapsible in naturewhich are much more comfortable to the patient, and may be made in amore economic, and environmentally conscious, way as the collapsiblereservoir will necessitate a smaller volume of plastic to produce. Thereservoir incorporates some means of removably attaching to the pumpbody, which allows the reservoir to be conveniently detached andreplaced by the patient. In this embodiment, a connector 78 is attachedto the reservoir, which mates to a counterpart receptor on the pumphousing body.

As seen in FIG. 13, the reservoir unit comprises a pair of independentreservoirs as described above. The reservoir thus may contain severalchannels to allow the fluid from multiple drainage structures to beindependently collected. These may be necessary if the healthcareprofessional desires to independently record the collected fluidamounts. Furthermore, the reservoir may be graduated, either by adheringa label or paint to the reservoir, or by embossing the plastic. Thesegraduations allow the fluid collected fluid amount to be easilyassessed.

The reservoir may also contain a substance intended to sterilize thecollected fluid, and may also cause the fluid to congeal. This isnecessary for the reservoir to be disposed of as “white bag” waste, orwaste which may be disposed of in landfill without additional treatment.This substance may be contained in a pouch or container within thereservoir or may be freely distributed inside of the reservoir. Thispouch or container may be ruptured by the patient in order to disbursethe contents, or may simply dissolve within a convenient period of time.

The reservoir or manifold, or both, may further comprise one or moresensors or measurement devices 400, 402, 404, internally or externally,or both. These sensors provide diagnostic value in taking variousmeasurements associated with the collected fluid. Measurements caninclude and are not limited to collected fluid amount, pH, certain knownharmful mediators (cytokines, chemokines, reactive oxygen species),protein levels, blood content, etc. For example, amount of fluidcollected can be an indicator of possible seroma development in somehernia surgeries. Additionally, pH has also been shown to act as anindicator of possible seroma formation. The present invention thusallows for the detection of infectious materials, and any otherchemicals or substances which may indicate infection, or the presence ofsome medical condition which may naturally arise in response to thesurgical procedure, initial pathology, or additional complications (ofeither the surgical procedure or the initial pathology) in the fluidcollected from percutaneous (internal) wounds. Sensors may also belocated in the pump unit.

Detection of a full reservoir may be accomplished by counting therevolutions of the peristaltic pump, or cycles of the positivedisplacement pump, and then calculating the total displaced fluid. Thisis made possible because the peristaltic, or positive displacement pumpmoves a nearly constant amount of fluid or gas with each revolution ofits motor. The device may be powered by either consumable orrechargeable batteries 85 which are held in a battery holder.

A circuit control board 81 comprising some or all required electricalcomponents controls the operation of the device. The control board maytake as inputs, and make decisions regarding, the following: user inputsvia interface buttons; battery charge level; need to change reservoir;device temperature; current magnitude of negative pressure; presence ofblockage in tubing; or the characteristics of the collected fluids.These characteristics may include, but are not limited to, thefollowing: total collected amount (either total or per drainagestructure); rate of fluid collection (total or per drainage structure)on the time scales of hours, days, or weeks; presence of infectiousmaterials; and any other chemicals or substances which may indicateinfection, or the presence of some medical condition which may naturallyarise in response to the surgical procedure, initial pathology, oradditional complications (of either the surgical procedure or theinitial pathology) in the fluid collected from percutaneous (internal)wounds.

The user interface may comprise a single push-button 75, which controlsan on/off or pause function, as well as any other functions which aredesirable for the operation of the device. One operation may be theselection of desired level of negative pressure. The interface may alsoconsist of a series of lights or a screen which alerts the user tovarious conditions including, but not limited to, device power state(off/on/paused), selected pressure level, battery charge level, need tochange battery, reservoir fill level, need to change reservoir,insufficient vacuum seal at any point in the system, or presence ofinfections materials, and any other chemicals or substances which mayindicate infection, or the presence of some medical condition. Thedevice may apply a negative pressure in the range of 50 mmHg to 700 mmHgbelow ambient pressure either continuously or intermittently, or operatesolely in range from 200 mmHg and 700 mmHg below ambient pressure,either continuously or intermittently. The device may create a constantnegative pressure of a desired amount and then allow the motors tomomentarily stop, until a time when the onboard pressure sensors detectthat the applied pressure has fallen below some desired threshold.Alternatively, the pumps may apply pressure based on a time incrementrather than a pressure level.

FIG. 14 shows a perspective view of the assembled pump unit device 87and reservoir 88 as detailed above in the description of FIG. 13. Inthis embodiment, the pump unit is relatively flat and rectangular, withrounded edges and corners.

FIGS. 15A-C show several views of another exemplary embodiment of theassembled pump unit device. In this embodiment, the edges and cornersmay be more rounded and the entire unit may be curved, as shown. Thefront or top of the device provides a user interface comprising a singlepush-button 90, and lights 96 which indicate the status of the unit(which may include but not be limited to on/off, device paused,reservoir full, or faulty tubing connection). The unit may comprise two(or more, as described above) fluid inlets 91, which provide theconnection for two drainage structures, and two (or more, to correspondto the fluid inlets) fluid outlets 92, which allow the fluid to betransported to the collection reservoir. As seen in FIG. 15C, thehousing 93 is curved in order to conform to the shape of the humanabdomen on which the device will be worn. The device may curves not onlyalong the horizontal axis (i.e., length-wise), but also along thevertical axis (i.e., width-wise).

FIGS. 16-23 yet another embodiment of the pump unit 120 and reservoir140 of the present invention, unconnected and connected. FIGS. 20-23show the interior of the pump unit (i.e., with the front half of thepump unit housing removed. In this embodiment, the pump unit 120 iscurved in a similar manner to the pump unit shown in FIGS. 15A-C. A pairof inlet ports/connectors 122 with one-way valves and inlet fluidchambers 134 are located near one end. A push-button interface 124 islocated on the top or front of the pump housing, and a series of lights126 are located on the side near the inlet ports (which is generally thetop side, when the unit is worn). A battery cover 128 allows access tothe batteries 130, which provide power to the circuit control board 132and the pump motors 138. Pumps 136 move fluid to the outletports/connectors 154, which are contained in the reservoir holder 150.Pairs of one-way valves 142 extend from one end of the reservoir unit140 (which contains two independent reservoirs in the embodiment shown),and are inserted into the outlet ports/connectors 154 to attach thereservoir unit to the pump unit. One or more rigid or semi-rigid guides146 may be provided to fit into corresponding slots or holes in thereservoir holder 150. This establishes connection with a sensor orswitch, which enables the control board in the pump unit to determinewhether the reservoir unit is attached, as described below. The guidesalso may help ensure accurate connection and prevent damage to theone-way valves or other connection elements. One or more quick-releasetabs or buttons 152 may be provided to allow the reservoir unit to bedisengaged and easily removed when pressed.

In several embodiments, as seen in FIG. 25, the fluid inlet ports 310may further comprise a grate or mesh 312, which breaks-up or divides anyparticles or similar larger material in the fluid which may have beencollected during operation. Alternatively, as seen in FIGS. 26A-C, thefluid inlet ports 310 may comprise a rotating blade 320 or rotaryapparatus for the same purpose. The blade 320 may spin within the fixedport by either a powered motor or by the power provided by movement ofthe fluid. In the latter case, the blade has geometry to transform thefluid flow to rotational force, as well as separate geometry to break-upor divide particles or similar larger material as described above.

In yet another exemplary embodiment, filters 340 are provided on areservoir connection unit 330 which is attached to one end of thereservoir unit 140. When the reservoir connection unit is used to attachthe reservoir unit 140 to the pump unit 120, the filter arm 342 withfilters 340 is inserted into a slot in the end of the pump unit, so thefilters 340 are inserted into the fluid flow lines in the body of thepump unit 120. When the reservoir unit is removed (such as by pressingthe quick release latch 348), the reservoir connection unit and filtersare also removed. The reservoir connection unit and filters can bedisposed of with the reservoir. In one embodiment, the filters orreservoir connection unit, or both, may be removable from the reservoirunit, and cleaned for re-use.

In yet another embodiment of the invention, the reservoir unit preventsre-connection to the pump unit after an initial connection to the pumpunit (or other suction apparatus). This prevents re-attachment of apresumably full reservoir unit, and the attempted movement of fluid intoa full fluid collection reservoir.

In a further embodiment of the invention, the pump control unit candetect whether a reservoir unit is connected to the outletports/connections, and prevents normal operation (i.e., the pumping offluid) without a reservoir present to contain the fluid. The detectionmechanism may comprise a mechanical switch or latch, the formation orbreaking of an optical pathway, or similar mechanism appropriate fordetermining or confirming proximity.

The various embodiments of the present invention thus providesubstantial improvements and advantages over the prior art. First, thepresent invention allows multiple drainage tubes to be connected to thesame source of negative pressure. Prior art devices lack thefunctionality to allow the combination of multiple drainage tubes into acommon source of negative pressure, thus requiring patients in surgeriesnecessitating multiple drains to wear multiple instances of thepreviously described device. Second, the present invention also placesthe reservoir after the negative pressure source. Prior art systemsrequire the reservoir to be placed between the tubing leading from theinternal wound site and the source of the negative pressure, whichimpairs functioning of the device. For example, gravity's action on thefluid to provide an air space on which the source of negative pressuremay act prevents prior art devices from functioning optimally while thepatient is in the prone or supine position. Furthermore, the placementof the reservoir in prior art devices increases the working distancebetween the source of negative pressure and the internal wound,necessitating that it act on a larger volume, reducing the efficiency ofthe device, and creating a source of oscillating pressure in the case ofa temporary blockage which is suddenly freed. Third, prior art devicesmake use of a perforated internal drain which allows the collection offluid. The present system comprises a manifold which allows the use ofthe unique internal drain described herein or the use of one or more ofthe many conventional internal drainage structures which the surgeon mayprefer. Further, the present invention incorporates adaptor fittingswhich allow any size or sizes (in the case of multiple drain lines) tobe utilized.

Additionally, prior art devices prescribe the application of a pressureregime from 125 mmHg to 200 mmHg below atmospheric. At this range, it isunlikely that the device will impart sufficient force on any impedimentto flow which may become lodged in the drainage tubing such as a mass ofclotted blood, fibrous material, or small portion of tissue. The presentinvention may operate at a pressure above 200 mmHg for certain periodsof operation, such as the initial drawing together of the separated(surgically or otherwise) tissue and the clearing of a blockage. Atother times, the present invention may operate at lower pressures inorder to allow a more passive means of suctioning. Further, prior artdevices do not incorporate a disposable reservoir, and do not allowneutralizing any odor from the collected fluid. The present inventioncomprises a fluid reservoir inherently designed to be disposable, and isplaced downstream from the source of negative pressure, negating thepreviously described problems with prior art devices.

Prior art devices do not allow for the accurate measurement ofcollection fluid, or derivative measurements. The present inventionallows for the measurement of the amount of collected fluid in eitherthe input manifold or the reservoir, and further calculates thecalculation of the percentage of collected fluid to air which wouldallow for the prediction of poor suturing and possibly surgical siteinfection (SSI). To accomplish this, the present invention carries outthe following steps:

-   -   1. Calculating the amount of total volume (air plus liquid)        collected via counting revolutions of peristaltic rotor.    -   2. Calculating the collected fluid amount by positioning a        series of electrode pairs acting as graduations in the reservoir        or by making use of the fluid measurement units in the manifold.    -   3. Calculating the ratio of total collected volume to total        collected fluid.

In order to provide a context for the various computer-implementedaspects of the invention, the following discussion provides a brief,general description of a suitable computing environment in which thevarious aspects of the present invention may be implemented. A computingsystem environment is one example of a suitable computing environment,but is not intended to suggest any limitation as to the scope of use orfunctionality of the invention. A computing environment may contain anyone or combination of components discussed below, and may containadditional components, or some of the illustrated components may beabsent. Various embodiments of the invention are operational withnumerous general purpose or special purpose computing systems,environments or configurations. Examples of computing systems,environments, or configurations that may be suitable for use withvarious embodiments of the invention include, but are not limited to,personal computers, laptop computers, computer servers, computernotebooks, hand-held devices, microprocessor-based systems,multiprocessor systems, TV set-top boxes and devices, programmableconsumer electronics, cell phones, personal digital assistants (PDAs),tablets, smart phones, touch screen devices, smart TV, internet enabledappliances, internet enabled security systems, internet enabled gamingsystems, internet enabled watches; internet enabled cars (ortransportation), network PCs, minicomputers, mainframe computers,embedded systems, virtual systems, distributed computing environments,streaming environments, volatile environments, and the like.

Embodiments of the invention may be implemented in the form ofcomputer-executable instructions, such as program code or programmodules, being executed by a computer, virtual computer, or computingdevice. Program code or modules may include programs, objects,components, data elements and structures, routines, subroutines,functions and the like. These are used to perform or implementparticular tasks or functions. Embodiments of the invention also may beimplemented in distributed computing environments. In such environments,tasks are performed by remote processing devices linked via acommunications network or other data transmission medium, and data andprogram code or modules may be located in both local and remote computerstorage media including memory storage devices such as, but not limitedto, hard drives, solid state drives (SSD), flash drives, USB drives,optical drives, and internet-based storage (e.g., “cloud” storage).

In one embodiment, a computer system comprises multiple client devicesin communication with one or more server devices through or over anetwork, although in some cases no server device is used. In variousembodiments, the network may comprise the Internet, an intranet, WideArea Network (WAN), or Local Area Network (LAN). It should be noted thatmany of the methods of the present invention are operable within asingle computing device.

A client device may be any type of processor-based platform that isconnected to a network and that interacts with one or more applicationprograms. The client devices each comprise a computer-readable medium inthe form of volatile and/or nonvolatile memory such as read only memory(ROM) and random access memory (RAM) in communication with a processor.The processor executes computer-executable program instructions storedin memory. Examples of such processors include, but are not limited to,microprocessors, ASICs, and the like.

Client devices may further comprise computer-readable media incommunication with the processor, said media storing program code,modules and instructions that, when executed by the processor, cause theprocessor to execute the program and perform the steps described herein.Computer readable media can be any available media that can be accessedby computer or computing device and includes both volatile andnonvolatile media, and removable and non-removable media.Computer-readable media may further comprise computer storage media andcommunication media. Computer storage media comprises media for storageof information, such as computer readable instructions, data, datastructures, or program code or modules. Examples of computer-readablemedia include, but are not limited to, any electronic, optical,magnetic, or other storage or transmission device, a floppy disk, harddisk drive, CD-ROM, DVD, magnetic disk, memory chip, ROM, RAM, EEPROM,flash memory or other memory technology, an ASIC, a configuredprocessor, CDROM, DVD or other optical disk storage, magnetic cassettes,magnetic tape, magnetic disk storage or other magnetic storage devices,or any other medium from which a computer processor can readinstructions or that can store desired information. Communication mediacomprises media that may transmit or carry instructions to a computer,including, but not limited to, a router, private or public network,wired network, direct wired connection, wireless network, other wirelessmedia (such as acoustic, RF, infrared, or the like) or othertransmission device or channel. This may include computer readableinstructions, data structures, program modules or other data in amodulated data signal such as a carrier wave or other transportmechanism. Said transmission may be wired, wireless, or both.Combinations of any of the above should also be included within thescope of computer readable media. The instructions may comprise codefrom any computer-programming language, including, for example, C, C++,C#, Visual Basic, Java, and the like.

Components of a general purpose client or computing device may furtherinclude a system bus that connects various system components, includingthe memory and processor. A system bus may be any of several types ofbus structures, including, but not limited to, a memory bus or memorycontroller, a peripheral bus, and a local bus using any of a variety ofbus architectures. Such architectures include, but are not limited to,Industry Standard Architecture (ISA) bus, Micro Channel Architecture(MCA) bus, Enhanced ISA (EISA) bus, Video Electronics StandardsAssociation (VESA) local bus, and Peripheral Component Interconnect(PCI) bus.

Computing and client devices also may include a basic input/outputsystem (BIOS), which contains the basic routines that help to transferinformation between elements within a computer, such as during start-up.BIOS typically is stored in ROM. In contrast, RAM typically containsdata or program code or modules that are accessible to or presentlybeing operated on by processor, such as, but not limited to, theoperating system, application program, and data.

Client devices also may comprise a variety of other internal or externalcomponents, such as a monitor or display, a keyboard, a mouse, atrackball, a pointing device, touch pad, microphone, joystick, satellitedish, scanner, a disk drive, a CD-ROM or DVD drive, or other input oroutput devices. These and other devices are typically connected to theprocessor through a user input interface coupled to the system bus, butmay be connected by other interface and bus structures, such as aparallel port, serial port, game port or a universal serial bus (USB). Amonitor or other type of display device is typically connected to thesystem bus via a video interface. In addition to the monitor, clientdevices may also include other peripheral output devices such asspeakers and printer, which may be connected through an outputperipheral interface.

Client devices may operate on any operating system capable of supportingan application of the type disclosed herein. Client devices also maysupport a browser or browser-enabled application. Examples of clientdevices include, but are not limited to, personal computers, laptopcomputers, personal digital assistants, computer notebooks, hand-helddevices, cellular phones, mobile phones, smart phones, pagers, digitaltablets, Internet appliances, and other processor-based devices. Usersmay communicate with each other, and with other systems, networks, anddevices, over the network through the respective client devices.

Thus, it should be understood that the embodiments and examplesdescribed herein have been chosen and described in order to bestillustrate the principles of the invention and its practicalapplications to thereby enable one of ordinary skill in the art to bestutilize the invention in various embodiments and with variousmodifications as are suited for particular uses contemplated. Eventhough specific embodiments of this invention have been described, theyare not to be taken as exhaustive. There are several variations thatwill be apparent to those skilled in the art.

What is claimed is:
 1. A device for collection of internal fluid from awound or incision comprising: A) a housing comprising: i) at least onefluid inlet connector, ii) a fluid chamber comprising at least onepressure sensing element, iii) at least one peristaltic or positivedisplacement pump unit, iv) a control unit including a circuit controlboard, and v) at least one outlet port; and B) at least one fluidcollector connected to said at least one outlet port for collection offluid drained from said wound or incision; wherein said at least onefluid inlet connector is configured to connect to a drainage structurepositioned within said wound or incision; wherein said at least onefluid inlet connector is in fluid communication with said fluid chamberand said fluid chamber is positioned downstream from said at least onefluid inlet connector; wherein said fluid chamber is in fluidcommunication with said at least one peristaltic or positivedisplacement pump unit; wherein said at least one peristaltic orpositive displacement pump unit is in fluid communication with said atleast one outlet port of said housing; wherein said circuit controlboard of said control unit is configured to monitor the pressuredeveloped by said at least one peristaltic or positive displacement pumpunit in order to selectively run or momentarily stop said at least oneperistaltic or positive displacement pump unit to regulate the pressuredelivered to the wound or incision site by receiving input data fromsaid at least one pressure-sensing element; wherein said at least oneperistaltic or positive displacement pump unit is configured to create anegative pressure to drain said fluid therethrough into said at leastone peristaltic or positive displacement pump unit through said at leastone fluid inlet connector and to create a positive pressure between saidat least one peristaltic or positive displacement pump unit and said atleast one fluid collector to transport said fluid from said at least oneperistaltic or positive displacement pump unit to said at least onefluid collector through said at least one outlet port; and wherein allelectronic components for operation of components ii), iii), and iv) arepresent within said housing.
 2. The device of claim 1, wherein said atleast one fluid collector comprises one or more fluid reservoirs.
 3. Thedevice of claim 2, wherein said one or more fluid reservoirs areremovably attached to said at least one outlet port.
 4. The device ofclaim 3, wherein said one or more fluid reservoirs are disposable and ofa collapsible or non-collapsible nature.
 5. The device of claim 2,wherein said one or more fluid reservoirs comprise a fluid intake portand an air release port.
 6. The device of claim 5, wherein said one ormore fluid reservoirs comprise one or more air-permeable butliquid-impermeable membranes.
 7. The device of claim 5, wherein said oneor more fluid reservoirs are internally segmented or compartmented. 8.The device of claim 5, wherein said one or more fluid reservoirs arerigid or flexible, in whole or in part.
 9. The device of claim 5,wherein said fluid intake port comprises a one-way valve.
 10. The deviceof claim 5, further comprising an activated carbon section proximatesaid air release port.
 11. The device of claim 5, further comprisingmeans to measure the amount of fluid in said one or more fluidreservoirs.
 12. The device of claim 2, wherein said at least one pumpunit is a peristaltic pump with a central rolling mechanism sequentiallycompressing an internal flexible tubing.
 13. The device of claim 1,further comprising a first one-way valve at said at least one fluidinlet connector and a second one-way valve at said at least one outletport.
 14. The device of claim 1, further comprising a binder to whichsaid device is removably attached.
 15. The device of claim 1, whereinsaid pump unit further comprises a wireless communications unit towirelessly communicate some or all of said input data to an externalcomputing device.
 16. The device of claim 1, further comprising one ormore sensors adapted to measure biological or chemical properties orparameters, or combinations thereof, of the collected fluid, furtherwherein said properties or parameters include one or more pH, cytokines,chemokines, reactive oxygen species, or protein levels.
 17. The deviceof claim 1 wherein said device exhibits collection unit-fill detectionfacilitated by tracking operation of said pump at a known flow rate ordisplacement per amount time.